# FDA 483 - Wellman Advanced Materials, LLC - December 13, 2018

Source: https://www.globalkeysolutions.net/records/483/wellman-advanced-materials-llc/f7c27231-1478-491b-85ca-7ec23e7f52dd

> FDA 483 for Wellman Advanced Materials, LLC on December 13, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wellman Advanced Materials, LLC
- Inspection Date: 2018-12-13
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Wellman Advanced Materials, LLC in Johnsonville, SC, was inspected and cited for multiple significant deficiencies across its quality system, facilities, production, and laboratory controls. The observations indicate a lack of written procedures, inadequate quality control, poor facility maintenance, and insufficient training, posing potential risks to drug product quality and integrity.

## Related Officers

- [Owner/Inspector](https://www.globalkeysolutions.net/people/jared-p-stevens/11cd48ff-e61f-4448-98be-efe2f8377fc1)

Company: https://www.globalkeysolutions.net/companies/wellman-advanced-materials-llc/62f75a0a-fdd5-4179-b843-1d97e3860696

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7